United Kingdom
The manufacture, marketing authorisation and supply of equine veterinary medicines in all European Community member states is controlled by EU Directive 2004/28/EC. Implementation of the directive at member state level is achieved by national legislation. In the UK, veterinary medicines are regulated by the Veterinary Medicines Regulations, first introduced in 2005. The legislation is reviewed, revoked and renewed in October each year to enable to remain current and take account of changes both nationally and at EU level. In the UK the government agency responsible for veterinary medicines legislation is the Veterinary Medicines Directorate (www.vmd.gov.uk), which produces detailed guidance notes on the legislation and conducts the annual consultations and reviews. Overall, the Regulations aim to promote the safe and responsible use of veterinary medicines to protect the consumer, as well as promoting competition for the supply of veterinary medicines.
An important feature of the UK legislation is that owners or keepers of horses can permanently exclude their horse from the food chain by declaring the horse as not intended for human consumption in section IX of the passport. This allows the horse to be treated with a wider range of medicines than if it is intended to enter the food chain. If the declaration is not completed or the horse is declared as intended for human consumption, there are restrictions on the veterinary medicines that can be used for treatment since the horse is subject to the regulations relating to administering veterinary medicines to food producing animals.
The Veterinary Medicines Regulations operate in tandem with the Horse Passports Regulations 2004 (providing measures for the identification of horses) and Council Regulation 2377/90/EU on the residues of pharmacologically-active substances in foodstuffs of animal origin, designed to protect consumers against residues in meat, milk, eggs etc based on the Maximum Residue Limits (MRL) of substances in food stuffs following treatment. Based on MRL data, substances are divided into four categories (Annexes I-IV) by Council Regulation 2377/90/EU, but note that some substances do not appear in any of the Annexes. Originally, only substances listed in Annexes I-III could be used in horses intended for human consumption. From October 2007, substances that appear in the List of Substances Essential for the Treatment of Equidae (Council Regulation 1950/2006) can also be used in horses intended for human consumption, subject to a six month withdrawal period (www.vmd.gov.uk/ProductInfo/AuthMed/Essentialsubstances.pdf).
Medicines not licensed for a particular use in horses, or that do not have a marketing authorisation for use in horses at all, can be prescribed strictly under the rules of the Prescribing Cascade provided there is no suitable licensed alternative.
Excellent guidance and notes on the latest version of the Veterinary Medicines Regulations, together with a downloadable version of the UK legislation can be found at the VMD website on www.vmd.gov.uk/General/VMR/SI2539.htm and www.vmd.gov.uk/General/VMR/VMG07notes.htm.
BEVA, in common with FEEVA, is concerned that although the veterinary medicines and residues regulations have increased consumer safety they have resulted in a reduction in the number of licensed equine veterinary medicines, largely due to the high costs of meeting the dossier requirements to obtain marketing authorisations. An EU Task Force has recently made a series of recommendations on the actions required to maintain the availability of equine veterinary medicines in the EU www.hma.eu/204.html.